Methods, systems, and apparatuses for managing transducer array placement

ABSTRACT

Methods, systems, and apparatuses are described for managing placement of transducer arrays on a subject/patient.

CROSS REFERENCE TO RELATED PATENT APPLICATION

This application claims priority to U.S. Provisional Application No.62/842,674 filed May 3, 2019, herein incorporated by reference in itsentirety.

BACKGROUND

Tumor Treating Fields, or TTFields, are low intensity (e.g., 1-3 V/cm)alternating electrical fields within the intermediate frequency range(100-300 kHz). This non-invasive treatment targets solid tumors and isdescribed in U.S. Pat. No. 7,565,205, which is incorporated herein byreference in its entirety. TTFields disrupt cell division throughphysical interactions with key molecules during mitosis. TTFieldstherapy is an approved mono-treatment for recurrent glioblastoma, and anapproved combination therapy with chemotherapy for newly diagnosedpatients. These electrical fields are induced non-invasively bytransducer arrays (i.e., arrays of electrodes) placed directly on thepatient's scalp. TTFields also appear to be beneficial for treatingtumors in other parts of the body.

The efficacy of TTFields therapy increases as the intensity of theelectric field increases. Changing the positioning of the transducerarrays on a patient's scalp (and/or other parts of the body) affects theintensity of the electric field in a target region. Determining how thepositioning of transducer arrays may be changed while maintaining atarget intensity of the electric field in the target region isdifficult, labor-intensive, and time-consuming process.

SUMMARY

Described are methods comprising generating a three-dimensional (3D)model of a portion of the subject's body, determining, based on the 3Dmodel and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, determining, from theplurality of transducer array layout maps, one or more sets oftransducer array layout maps, wherein each set of transducer arraylayout maps represents at least two transducer array layout maps withnon-overlapping positions of a plurality of pairs of positions fortransducer array placement, wherein the at least two transducer arraylayout maps satisfy a criterion, and causing display of the one or moresets of transducer array layout maps.

Also described are methods comprising generating a three-dimensional(3D) model of a portion of the subject's body, determining, based on the3D model and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, receiving a selection of afirst transducer array layout map of the plurality of transducer arraylayout maps, wherein the first transducer array layout map satisfies acriterion, determining, from the plurality of transducer array layoutmaps, one or more associated transducer array layout maps, wherein eachassociated transducer array layout map comprises positions fortransducer array placement that do not overlap positions for transducerarray placement of the first transducer array layout map, wherein eachassociated transducer array layout map satisfies the criterion,receiving a selection of a second transducer array layout map from theplurality of associated transducer array layout maps, and causingdisplay of the first transducer array layout map and the secondtransducer array layout map.

Also described are methods comprising generating a three-dimensional(3D) model of a portion of the subject's body, determining, based on the3D model and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, receiving a selection of afirst transducer array layout map and a second transducer array layoutmap of the plurality of transducer array layout maps, determining, basedon the first transducer array layout map and the second transducer arraylayout map, an overlap condition, and causing display of the overlapcondition.

Additional advantages will be set forth in part in the description whichfollows or may be learned by practice. The advantages will be realizedand attained by means of the elements and combinations particularlypointed out in the appended claims. It is to be understood that both theforegoing general description and the following detailed description areexemplary and explanatory only and are not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

To easily identify the discussion of any particular element or act, themost significant digit or digits in a reference number refer to thefigure number in which that element is first introduced.

FIG. 1 shows an example apparatus for electrotherapeutic treatment.

FIG. 2 shows an example transducer array.

FIG. 3A and FIG. 3B illustrate an example application of the apparatusfor electrotherapeutic treatment.

FIG. 4A shows transducer arrays placed on a patient's head.

FIG. 4B shows transducer arrays placed on a patient's abdomen.

FIG. 5A, the transducer arrays placed on a patient's torso.

FIG. 5B shows transducer arrays placed on a patient's pelvis

FIG. 6 is a block diagram of a system for managing transducer arrayplacement.

FIG. 7 illustrates electrical field magnitude and distribution (in V/cm)shown in coronal view from a finite element method simulation model.

FIG. 8A shows a three-dimensional array layout map 800.

FIG. 8B shows placement of transducer arrays on the scalp of a patient.

FIG. 9A shows an axial T1 sequence slice containing most apical image,including orbits used to measure head size.

FIG. 9B shows a coronal T1 sequence slice selecting image at level ofear canal used to measure head size.

FIG. 9C shows a postcontrast T1 axial image shows maximal enhancingtumor diameter used to measure tumor location.

FIG. 9D shows a postcontrast T1 coronal image shows maximal enhancingtumor diameter used to measure tumor location.

FIG. 10 shows an example system for managing transducer array placement.

FIGS. 11A-11D shows an example user interface for managing transducerarray placement.

FIG. 12 shows an example method for managing transducer array placement.

FIG. 13 shows an example method for managing transducer array placement.

FIG. 14 shows an example method for managing transducer array placement.

DETAILED DESCRIPTION

Before the present methods and systems are disclosed and described, itis to be understood that the methods and systems are not limited tospecific methods, specific components, or to particular implementations.It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only and is not intended tobe limiting.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Ranges may be expressed herein as from “about” oneparticular value, and/or to “about” another particular value. When sucha range is expressed, another embodiment includes—from the oneparticular value and/or to the other particular value. Similarly, whenvalues are expressed as approximations, by use of the antecedent“about,” it will be understood that the particular value forms anotherembodiment. It will be further understood that the endpoints of each ofthe ranges are significant both in relation to the other endpoint, andindependently of the other endpoint.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where said event or circumstance occurs and instances where itdoes not.

Throughout the description and claims of this specification, the word“comprise” and variations of the word, such as “comprising” and“comprises,” means “including but not limited to,” and is not intendedto exclude, for example, other components, integers or steps.“Exemplary” means “an example of” and is not intended to convey anindication of a preferred or ideal embodiment. “Such as” is not used ina restrictive sense, but for explanatory purposes.

Disclosed are components that can be used to perform the disclosedmethods and systems. These and other components are disclosed herein,and it is understood that when combinations, subsets, interactions,groups, etc. of these components are disclosed that while specificreference of each various individual and collective combinations andpermutation of these may not be explicitly disclosed, each isspecifically contemplated and described herein, for all methods andsystems. This applies to all aspects of this application including, butnot limited to, steps in disclosed methods. Thus, if there are a varietyof additional steps that can be performed it is understood that each ofthese additional steps can be performed with any specific embodiment orcombination of embodiments of the disclosed methods.

The present methods and systems may be understood more readily byreference to the following detailed description of preferred embodimentsand the examples included therein and to the Figures and their previousand following description.

As will be appreciated by one skilled in the art, the methods andsystems may take the form of an entirely hardware embodiment, anentirely software embodiment, or an embodiment combining software andhardware aspects. Furthermore, the methods and systems may take the formof a computer program product on a computer-readable storage mediumhaving computer-readable program instructions (e.g., computer software)embodied in the storage medium. More particularly, the present methodsand systems may take the form of web-implemented computer software. Anysuitable computer-readable storage medium may be utilized including harddisks, CD-ROMs, optical storage devices, or magnetic storage devices.

Embodiments of the methods and systems are described below withreference to block diagrams and flowchart illustrations of methods,systems, apparatuses and computer program products. It will beunderstood that each block of the block diagrams and flowchartillustrations, and combinations of blocks in the block diagrams andflowchart illustrations, respectively, can be implemented by computerprogram instructions. These computer program instructions may be loadedonto a general purpose computer, special purpose computer, or otherprogrammable data processing apparatus to produce a machine, such thatthe instructions which execute on the computer or other programmabledata processing apparatus create a means for implementing the functionsspecified in the flowchart block or blocks.

These computer program instructions may also be stored in acomputer-readable memory that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablememory produce an article of manufacture including computer-readableinstructions for implementing the function specified in the flowchartblock or blocks. The computer program instructions may also be loadedonto a computer or other programmable data processing apparatus to causea series of operational steps to be performed on the computer or otherprogrammable apparatus to produce a computer-implemented process suchthat the instructions that execute on the computer or other programmableapparatus provide steps for implementing the functions specified in theflowchart block or blocks.

Accordingly, blocks of the block diagrams and flowchart illustrationssupport combinations of means for performing the specified functions,combinations of steps for performing the specified functions and programinstruction means for performing the specified functions. It will alsobe understood that each block of the block diagrams and flowchartillustrations, and combinations of blocks in the block diagrams andflowchart illustrations, can be implemented by special purposehardware-based computer systems that perform the specified functions orsteps, or combinations of special purpose hardware and computerinstructions.

TTFields, also referred to herein as alternating electrical fields, areestablished as an anti-mitotic cancer treatment modality because theyinterfere with proper micro-tubule assembly during metaphase andeventually destroy the cells during telophase and cytokinesis. Theefficacy increases with increasing field strength and the optimalfrequency is cancer cell line dependent with 200 kHz being the frequencyfor which inhibition of glioma cells growth caused by TTFields ishighest. For cancer treatment, non-invasive devices were developed withcapacitively coupled transducers that are placed directly at the skinregion close to the tumor, for example, for patients with GlioblastomaMultiforme (GBM), the most common primary, malignant brain tumor inhumans.

Because the effect of TTFields is directional with cells dividingparallel to the field affected more than cells dividing in otherdirections, and because cells divide in all directions, TTFields aretypically delivered through two pairs of transducer arrays that generateperpendicular fields within the treated tumor. More specifically, onepair of transducer arrays may be located to the left and right (LR) ofthe tumor, and the other pair of transducer arrays may be locatedanterior and posterior (AP) to the tumor. Cycling the field betweenthese two directions (i.e., LR and AP) ensures that a maximal range ofcell orientations is targeted. Other positions of transducer arrays arecontemplated beyond perpendicular fields. In an embodiment, asymmetricpositioning of three transducer arrays is contemplated wherein one pairof the three transducer arrays may deliver alternating electrical fieldsand then another pair of the three transducer arrays may deliver thealternating electrical fields, and the remaining pair of the threetransducer arrays may deliver the alternating electrical fields.

In-vivo and in-vitro studies show that the efficacy of TTFields therapyincreases as the intensity of the electrical field increases. Therefore,optimizing array placement on the patient's scalp to increase theintensity in the diseased region of the brain is standard practice forthe Optune system. Array placement optimization may be performed by“rule of thumb” (e.g., placing the arrays on the scalp as close to thetumor as possible) measurements describing the geometry of the patient'shead, tumor dimensions, and/or tumor location. Measurements used asinput may be derived from imaging data. Imaging data is intended toinclude any type of visual data, such as for example, single-photonemission computed tomography (SPECT) image data, x-ray computedtomography (x-ray CT) data, magnetic resonance imaging (MRI) data,positron emission tomography (PET) data, data that can be captured by anoptical instrument (e.g., a photographic camera, a charge-coupled device(CCD) camera, an infrared camera, etc.), and the like. In certainimplementations, image data may include 3D data obtained from orgenerated by a 3D scanner (e.g., point cloud data). Optimization canrely on an understanding of how the electrical field distributes withinthe head as a function of the positions of the array and, in someaspects, take account for variations in the electrical propertydistributions within the heads of different patients. A plurality oftransducer array maps that indicate optimized positioning for transducerarrays on a patient's body that satisfy various criterion (e.g., providea minimum and/or maximum strength of an electric field within aregion-of-interest (ROI), power density within the ROI, etc.) may bedetermined.

Since, the positioning of the transducer arrays on a patient's scalp(and/or other parts of the body) affects the intensity of the electricfield in a ROI and/or target region, transducer array maps that enablethe positioning of transducer arrays to be changed while maintaining atarget intensity of the electric field in the ROI and/or target regionmay be determined.

FIG. 1 shows an example apparatus 100 for electrotherapeutic treatment.Generally, the apparatus 100 may be a portable, battery or power supplyoperated device which produces alternating electrical fields within thebody by means of non-invasive surface transducer arrays. The apparatus100 may comprise an electrical field generator 102 and one or moretransducer arrays 104. The apparatus 100 may be configured to generatetumor treatment fields (TTFields) (e.g., at 150 kHz) via the electricalfield generator 102 and deliver the TTFields to an area of the bodythrough the one or more transducer arrays 104. The electrical fieldgenerator 102 may be a battery and/or power supply operated device. Inan embodiment, the one or more transducer arrays 104 are uniformlyshaped. In an embodiment, the one or more transducer arrays 104 are notuniformly shaped.

The electrical field generator 102 may comprise a processor 106 incommunication with a signal generator 108. The electrical fieldgenerator 102 may comprise control software 110 configured forcontrolling the performance of the processor 106 and the signalgenerator 108.

The signal generator 108 may generate one or more electric signals inthe shape of waveforms or trains of pulses. The signal generator 108 maybe configured to generate an alternating voltage waveform at frequenciesin the range from about 50 KHz to about 500 KHz (preferably from about100 KHz to about 300 KHz) (e.g., the TTFields). The voltages are suchthat the electrical field intensity in tissue to be treated is in therange of about 0.1 V/cm to about 10 V/cm.

One or more outputs 114 of the electrical field generator 102 may becoupled to one or more conductive leads 112 that are attached at one endthereof to the signal generator 108. The opposite ends of the conductiveleads 112 are connected to the one or more transducer arrays 104 thatare activated by the electric signals (e.g., waveforms). The conductiveleads 112 may comprise standard isolated conductors with a flexiblemetal shield and may be grounded to prevent the spread of the electricalfield generated by the conductive leads 112. The one or more outputs 114may be operated sequentially. Output parameters of the signal generator108 may comprise, for example, an intensity of the field, a frequency ofthe waves (e.g., treatment frequency), and a maximum allowabletemperature of the one or more transducer arrays 104. The outputparameters may be set and/or determined by the control software 110 inconjunction with the processor 106. After determining a desired (e.g.,optimal) treatment frequency, the control software 110 may cause theprocessor 106 to send a control signal the signal generator 108 thatcauses the signal generator 108 to output the desired treatmentfrequency to the one or more transducer arrays 104.

The one or more transducer arrays 104 may be configured in a variety ofshapes and positions so as to generate an electrical field of thedesired configuration, direction and intensity at a target volume so asto focus treatment. The one or more transducer arrays 104 may beconfigured to deliver two perpendicular field directions through avolume of interest.

The one or more transducer arrays 104 arrays may comprise one or moreelectrodes 116. The one or more electrodes 116 may be made from anymaterial with a high dielectric constant. The one or more electrodes 116may comprise, for example, one or more insulated ceramic discs. Theelectrodes 116 may be biocompatible and coupled to a flexible circuitboard 118. The electrodes 116 may be configured so as to not come intodirect contact with the skin as the electrodes 116 are separated fromthe skin by a layer of conductive hydrogel (not shown) (similar to thatfound on electrocardiogram pads).

The electrodes 116, the hydrogel, and the flexible circuit board 118 maybe attached to a hypo-allergenic medical adhesive bandage 120 to keepthe one or more transducer arrays 104 in place on the body and incontinuous direct contact with the skin. Each transducer array 104 maycomprise one or more thermistors (not shown), for example 8 thermistors,(accuracy ± 1° C). to measure skin temperature beneath the transducerarrays 104. The thermistors may be configured to measure skintemperature periodically, for example, every second. The thermistors maybe read by the control software 110 while the TTFields are not beingdelivered in order to avoid any interference with the temperaturemeasurements.

If the temperature measured is below a pre-set maximum temperature(Tmax), for example 38.5-40.0° C. ± 0.3° C., between two subsequentmeasures, the control software 110 can increase current until thecurrent reaches maximal treatment current (for example, 4 Ampspeak-to-peak). If the temperature reaches Tmax + 0.3° C. and continuesto rise, the control software 110 can lower the current. If thetemperature rises to 41° C., the control software 110 can shut off theTTFields therapy and an overheating alarm can be triggered.

The one or more transducer arrays 104 may vary in size and may comprisevarying numbers of electrodes 116, based on patient body sizes and/ordifferent therapeutic treatments. For example, in the context of thechest of a patient, small transducer arrays may comprise 13 electrodeseach, and large transducer arrays may comprise 20 electrodes each, withthe electrodes serially interconnected in each array. For example, asshown in FIG. 2, in the context of the head of a patient, eachtransducer array may comprise 9 electrodes each, with the electrodesserially interconnected in each array.

A status of the apparatus 100 and monitored parameters may be stored amemory (not shown) and can be transferred to a computing device over awired or wireless connection. The apparatus 100 may comprise a display(not shown) for displaying visual indicators, such as, power on,treatment on, alarms, and low battery.

FIG. 3A and FIG. 3B illustrate an example application of the apparatus100. A transducer array 104 a and a transducer array 104 b are shown,each incorporated into a hypo-allergenic medical adhesive bandage 120 aand 120 b, respectively. The hypo-allergenic medical adhesive bandages120 a and 120 b are applied to skin surface 302. A tumor 304 is locatedbelow the skin surface 302 and bone tissue 306 and is located withinbrain tissue 308. The electrical field generator 102 causes thetransducer array 104 a and the transducer array 104 b to generatealternating electrical fields 310 within the brain tissue 308 thatdisrupt rapid cell division exhibited by cancer cells of the tumor 304.The alternating electrical fields 310 have been shown in non-clinicalexperiments to arrest the proliferation of tumor cells and/or to destroythem. Use of the alternating electrical fields 310 takes advantage ofthe special characteristics, geometrical shape, and rate of dividingcancer cells, which make them susceptible to the effects of thealternating electrical fields 310. The alternating electrical fields 310alter their polarity at an intermediate frequency (on the order of100-300 kHz). The frequency used for a particular treatment may bespecific to the cell type being treated (e.g., 150 kHz for MPM). Thealternating electrical fields 310 have been shown to disrupt mitoticspindle microtubule assembly and to lead to dielectrophoreticdislocation of intracellular macromolecules and organelles duringcytokinesis. These processes lead to physical disruption of the cellmembrane and to programmed cell death (apoptosis).

Because the effect of the alternating electrical fields 310 isdirectional with cells dividing parallel to the field affected more thancells dividing in other directions, and because cells divide in alldirections, alternating electrical fields 310 may be delivered throughtwo pairs of transducer arrays 104 that generate perpendicular fieldswithin the treated tumor. More specifically, one pair of transducerarrays 104 may be located to the left and right (LR) of the tumor, andthe other pair of transducer arrays 104 may be located anterior andposterior (AP) to the tumor. Cycling the alternating electrical fields310 between these two directions (e.g., LR and AP) ensures that amaximal range of cell orientations is targeted. In an embodiment, thealternating electrical fields 310 may be delivered according to asymmetric setup of transducer arrays 104 (e.g., four total transducerarrays 104, two matched pairs). In another embodiment, the alternatingelectrical fields 310 may be delivered according to an asymmetric setupof transducer arrays 104 (e.g., three total transducer arrays 104). Anasymmetric setup of transducer arrays 104 may engage two of the threetransducer arrays 104 to deliver the alternating electrical fields 310and then switch to another two of the three transducer arrays 104 todeliver the alternating electrical fields 310, and the like.

In-vivo and in-vitro studies show that the efficacy of TTFields therapyincreases as the intensity of the electrical field increases. Themethods, systems, and apparatuses described are configured foroptimizing array placement on the patient's scalp to increase theintensity in the diseased region of the brain.

As shown in FIG. 4A, the transducer arrays 104 may be placed on apatient's head. As shown in FIG. 4B, the transducer arrays 104 may beplaced on a patient's abdomen. As shown in FIG. 5A, the transducerarrays 104 may be placed on a patient's torso. As shown in FIG. 5B, thetransducer arrays 104 may be placed on a patient's pelvis. Placement ofthe transducer arrays 104 on other portions of a patient's body (e.g.,arm, leg, etc.) is specifically contemplated.

FIG. 6 is a block diagram depicting non-limiting examples of a system600 comprising a patient support system 602. The patient support system602 can comprise one or multiple computers configured to operate and/orstore an electrical field generator (EFG) configuration application 606,a patient modeling application 608, and/or imaging data 610. The patientsupport system 602 can comprise for example, a computing device. Thepatient support system 602 can comprise for example, a laptop computer,a desktop computer, a mobile phone (e.g., smartphone), a tablet, and thelike.

The patient modeling application 608 may be configured to generate athree dimensional model of a portion of a body of a patient (e.g., apatient model) according to the imaging data 610. The imaging data 610may comprise any type of visual data, such as for example, single-photonemission computed tomography (SPECT) image data, x-ray computedtomography (x-ray CT) data, magnetic resonance imaging (MRI) data,positron emission tomography (PET) data, data that can be captured by anoptical instrument (e.g., a photographic camera, a charge-coupled device(CCD) camera, an infrared camera, etc.), and the like. In certainimplementations, image data may include 3D data obtained from orgenerated by a 3D scanner (e.g., point cloud data). The patient modelingapplication 608 may also be configured to generate a three-dimensionalarray layout map based on the patient model and one or more electricalfield simulations.

In order to properly optimize array placement on a portion of apatient's body, the imaging data 610, such as MRI imaging data, may beanalyzed by the patient modeling application 608 to identify a region ofinterest that comprises a tumor. In the context of a patient's head, tocharacterize how electrical fields behave and distribute within thehuman head, modeling frameworks based on anatomical head models usingFinite Element Method (FEM) simulations may be used. These simulationsyield realistic head models based on magnetic resonance imaging (MRI)measurements and compartmentalize tissue types such as skull, whitematter, gray matter, and cerebrospinal fluid (CSF) within the head. Eachtissue type may be assigned dielectric properties for relativeconductivity and permittivity, and simulations may be run wherebydifferent transducer array configurations are applied to the surface ofthe model in order to understand how an externally applied electricalfield, of preset frequency, will distribute throughout any portion of apatient's body, for example, the brain. The results of thesesimulations, employing paired array configurations, a constant current,and a preset frequency of 200 kHz, have demonstrated that electricalfield distributions are relatively non-uniform throughout the brain andthat electrical field intensities exceeding 1 V/cm are generated in mosttissue compartments except CSF. These results are obtained assumingtotal currents with a peak-to-peak value of 1800 milliamperes (mA) atthe transducer array-scalp interface. This threshold of electrical fieldintensity is sufficient to arrest cellular proliferation in glioblastomacell lines. Additionally, by manipulating the configuration of pairedtransducer arrays, it is possible to achieve an almost tripling ofelectrical field intensity to a particular region of the brain as shownin FIG. 7. FIG. 7 illustrates electrical field magnitude anddistribution (in V/cm) shown in coronal view from a finite elementmethod simulation model. This simulation employs a left-right pairedtransducer array configuration.

In an aspect, the patient modeling application 608 may be configured todetermine a desired (e.g., optimal) transducer array layout for apatient based on the location and extent of the tumor. For example,initial morphometric head size measurements may be determined from theT1 sequences of a brain MRI, using axial and coronal views. Postcontrastaxial and coronal MRI slices may be selected to demonstrate the maximaldiameter of enhancing lesions. Employing measures of head size anddistances from predetermined fiducial markers to tumor margins, varyingpermutations and combinations of paired array layouts may be assessed inorder to generate the configuration which delivers maximal electricalfield intensity to the tumor site. As shown in FIG. 8A, the output maybe a three-dimensional array layout map 800. The three-dimensional arraylayout map 800 (e.g., a transducer array layout map) may be used by thepatient and/or caregiver in arranging arrays on the scalp during thenormal course of TTFields therapy as shown in FIG. 8B.

In an aspect, the patient modeling application 608 can be configured todetermine the three-dimensional array layout map for a patient. MRImeasurements of the portion of the patient that is to receive thetransducer arrays may be determined. By way of example, the MRImeasurements may be received via a standard Digital Imaging andCommunications in Medicine (DICOM) viewer. MRI measurement determinationmay be performed automatically, for example by way of artificialintelligence techniques or may be performed manually, for example by wayof a physician.

Manual MRI measurement determination may comprise receiving and/orproviding MRI data via a DICOM viewer. The MRI data may comprise scansof the portion of the patient that contains a tumor. By way of example,in the context of the head of a patient, the MRI data may comprise scansof the head that comprise one or more of a right fronto-temporal tumor,a right parieto-temporal tumor, a left fronto-temporal tumor, a leftparieto-occipital tumor, and/or a multi-focal midline tumor. FIG. 9A,FIG. 9B, FIG. 9C, and FIG. 9D show example MRI data showing scans of thehead of a patient. FIG. 9A shows an axial T1 sequence slice containingmost apical image, including orbits used to measure head size. FIG. 9Bshows a coronal T1 sequence slice selecting image at level of ear canalused to measure head size. FIG. 9C shows a postcontrast T1 axial imageshows maximal enhancing tumor diameter used to measure tumor location.FIG. 9D shows a postcontrast T1 coronal image shows maximal enhancingtumor diameter used to measure tumor location. MRI measurements maycommence from fiducial markers at the outer margin of the scalp andextend tangentially from a right-, anterior-, superior origin.Morphometric head size may be estimated from the axial T1 MRI sequenceselecting the most apical image which still included the orbits (or theimage directly above the superior edge of the orbits)

In an aspect, the MRI measurements may comprise, for example, one ormore of, head size measurements and/or tumor measurements. In an aspect,one or more MRI measurements may be rounded to the nearest millimeterand may be provided to a transducer array placement module (e.g.,software) for analysis. The MRI measurements may then be used togenerate the three-dimensional array layout map (e.g., three-dimensionalarray layout map 800).

The MRI measurements may comprise one or more head size measurementssuch as: a maximal antero-posterior (A-P) head size, commencingmeasurement from the outer margin of the scalp; a maximal width of thehead perpendicular to the A-P measurement: right to left lateraldistance; and/or a distance from the far most right margin of the scalpto the anatomical midline.

The MRI measurements may comprise one or more head size measurementssuch as coronal view head size measurements. Coronal view head sizemeasurements may be obtained on the T1 MRI sequence selecting the imageat the level of the ear canal (FIG. 9B). The coronal view head sizemeasurements may comprise one or more of: a vertical measurement fromthe apex of the scalp to an orthogonal line delineating the inferiormargin of the temporal lobes; a maximal right to left lateral headwidth; and/or a distance from the far right margin of the scalp to theanatomical midline.

The MRI measurements may comprise one or more tumor measurements, suchas tumor location measurements. The tumor location measurements may bemade using T1 postcontrast MRI sequences, firstly on the axial imagedemonstrating maximal enhancing tumor diameter (FIG. 9C). The tumorlocation measurements may comprise one or more of: a maximal A-P headsize, excluding the nose; a maximal right to left lateral diameter,measured perpendicular to the A-P distance; a distance from the rightmargin of the scalp to the anatomical midline; a distance from the rightmargin of the scalp to the closest tumor margin, measured parallel tothe right-left lateral distance and perpendicular to the A-Pmeasurement; a distance from the right margin of the scalp to thefarthest tumor margin, measured parallel to the right-left lateraldistance, perpendicular to the A-P measurement; a distance from thefront of the head, measured parallel to the A-P measurement, to theclosest tumor margin; and/or a distance from the front of the head,measured parallel to the A-P measurement, to the farthest tumor margin.

The one or more tumor measurements may comprise coronal view tumormeasurements. The coronal view tumor measurements may compriseidentifying the postcontrast T1 MRI slice featuring the maximal diameterof tumor enhancement (FIG. 9D). The coronal view tumor measurements maycomprise one or more of: a maximal distance from the apex of the scalpto the inferior margin of the cerebrum. In anterior slices, this wouldbe demarcated by a horizontal line drawn at the inferior margin of thefrontal or temporal lobes, and posteriorly, it would extend to thelowest level of visible tentorium; a maximal right to left lateral headwidth; a distance from the right margin of the scalp to the anatomicalmidline; a distance from the right margin of the scalp to the closesttumor margin, measured parallel to the right-left lateral distance; adistance from the right margin of the scalp to the farthest tumormargin, measured parallel to the right-left lateral distance; a distancefrom the apex of the head to the closest tumor margin, measured parallelto the superior apex to inferior cerebrum line; and/or a distance fromthe apex of the head to the farthest tumor margin, measured parallel tothe superior apex to inferior cerebrum line.

Other MRI measurements may be used, particularly when the tumor ispresent in another portion of the patient's body.

The MRI measurements may be used by the patient modeling application 608to generate a patient model. The patient model may then be used todetermine the three-dimensional array layout map (e.g.,three-dimensional array layout map 800). Continuing the example of atumor within the head of a patient, a healthy head model may begenerated which serves as a deformable template from which patientmodels can be created. When creating a patient model, the tumor may besegmented from the patient's MRI data (e.g., the one or more MRImeasurements). Segmenting the MRI data identifies the tissue type ineach voxel, and electric properties may be assigned to each tissue typebased on empirical data. Table 1 shows standard electrical properties oftissues that may be used in simulations. The region of the tumor in thepatient MRI data may be masked, and non-rigid registration algorithmsmay be used to register the remaining regions of the patient head on toa 3D discrete image representing the deformable template of the healthyhead model. This process yields a non-rigid transformation that maps thehealthy portion of the patient's head in to the template space, as wellas the inverse transformation that maps the template in to the patientspace. The inverse transformation is applied to the 3D deformabletemplate to yield an approximation of the patient head in the absence ofa tumor. Finally, the tumor (referred to as a region-of-interest (ROI))is planted back into the deformed template to yield the full patientmodel. The patient model may be a digital representation in threedimensional space of the portion of the patient's body, includinginternal structures, such as tissues, organs, tumors, etc.

TABLE 1 Tissue Type Conductivity, S/m Relative Permittivity Scalp 0.35000 Skull 0.08 200 Cerebrospinal fluid 1.79 110 Gray matter 0.25 3000White matter 0.12 2000 Enhancing tumor 0.24 2000 Enhancing nontumor 0.361170 Resection cavity 1.79 110 Necrotic tumor 1 110 Hematoma 0.3 2000Ischemia 0.18 2500 Atrophy 1 110 Air 0 0

Delivery of TTFields may then be simulated by the patient modelingapplication 608 using the patient model. Simulated electrical fielddistributions, dosimetry, and simulation-based analysis are described inU.S. Patent Publication No. 20190117956 A1 and Publication “Correlationof Tumor treating Fields Dosimetry to Survival Outcomes in NewlyDiagnosed Glioblastoma: A Large-Scale Numerical Simulation-basedAnalysis of Data from the Phase 3 EF-14 randomized Trial” by Ballo, etal. (2019) which are incorporated herein by reference in their entirety.

To ensure systematic positioning of the transducer arrays relative tothe tumor location, a reference coordinate system may be defined. Forexample, a transversal plane may initially be defined by conventional LRand anteroposterior (AP) positioning of the transducer arrays. Theleft-right direction may be defined as the x-axis, the AP direction maybe defined as the y-axis, and the cranio-caudal direction normal to thexy-plane may be defined as the z-axis.

After defining the coordinate system, transducer arrays may be virtuallyplaced on the patient model with their centers and longitudinal axes inthe xy-plane. A pair of transducer arrays may be systematically rotatedaround the z-axis of the head model, i.e. in the xy-plane, from 0 to 180degrees, thereby covering the entire circumference of the head (bysymmetry). The rotation interval may be, for example, 15 degrees,corresponding to approximately 2 cm translations, giving a total oftwelve different positions in the range of 180 degrees. Other rotationintervals are contemplated. Electrical field distribution calculationsmay be performed for each transducer array position relative to tumorcoordinates.

Electrical field distribution in the patient model may be determined bythe patient modeling application 608 using a finite element (FE)approximation of electrical potential. In general, the quantitiesdefining a time-varying electromagnetic field are given by the complexMaxwell equations. However, in biological tissues and at the low tointermediate frequency of TTFields (f =200kHz), the electromagneticwavelength is much larger than the size of the head and the electricpermittivity ε is negligible compared to the real-valued electricconductivity σ, i.e., where ω=2πf is the angular frequency. This impliesthat the electromagnetic propagation effects and capacitive effects inthe tissue are negligible, so the scalar electric potential may be wellapproximated by the static Laplace equation ∇·(σ∇ø)=0, with appropriateboundary conditions at the electrodes and skin. Thus, the compleximpedance is treated as resistive (i.e. reactance is negligible) andcurrents flowing within the volume conductor are, therefore, mainly free(Ohmic) currents. The FE approximation of Laplace's equation may becalculated using software, such as SimNIBS software (simnibs.org).Computations based on the Galerkin method and the residuals for theconjugate gradient solver are required to be <1E−9. Dirichlet boundaryconditions were used with the electric potential was set to (arbitrarilychosen) fixed values at each set of electrode arrays. The electric(vector) field may be calculated as the numerical gradient of theelectric potential and the current density (vector field) may becomputed from the electrical field using Ohm's law. The potentialdifference of the electrical field values and the current densities maybe linearly rescaled to ensure a total peak-to-peak amplitude for eacharray pair of 1.8 A, calculated as the (numerical) surface integral ofthe normal current density components over all triangular surfaceelements on the active electrode discs. The “dose” of TTFields maycalculated as the intensity (L2 norm) of the field vectors. The modeledcurrent may be assumed to be provided by two separate and sequentiallyactive sources each connected to a pair of 3×3 transducer arrays. Theleft and posterior arrays may be defined to be sources in thesimulations, while the right and anterior arrays were the correspondingsinks, respectively. However, as TTFields employ alternating fields,this choice is arbitrary and does not influence the results.

An average electrical field strength generated by transducer arraysplaced at multiple locations on the patient may be determined by thepatient modeling application 608 for one or more tissue types. In anaspect, the transducer array position that corresponds to the highestaverage electrical field strength in the tumor tissue type(s) may beselected as a desired (e.g., optimal) transducer array position for thepatient.

In some instances, transducer array placement positions, such asoptimized transducer array placement positions, may be determined foreffective and/or optimized TTFields treatment and/or therapy. Forexample, one or more users (e.g., a physicians, nurses, assistants,staff members, physicists, dosimetrists, etc.) may use a user interfaceto determine and/or generate transducer array layout maps (e.g.,three-dimensional array layout maps, etc.) for positioning transducerarrays on the body (e.g., head, torso, etc.) of a person (e.g., patient,subject, etc.) that will optimize TTFields treatment and/or therapywhile avoiding and/or limiting skin toxicity. For example, a pluralityof sets (e.g., groups, compendiums, etc.) of transducer array layoutmaps may be determined that each include transducer array layout mapsthat satisfy criteria or a criterion. A criterion may include apotential magnitude of an electric field distributed within aregion-of-interest (ROI) associated with a person (e.g., patient,subject, etc.), a potential power density associated with an electricfield distributed within the ROI, and an estimate of skin toxicityassociated with a portion of the body (e.g., head, torso, etc.) of theperson, and/or any other criterion. Sets of transducer array layout mapsof the plurality of sets of transducer array layout maps may bedetermined that include two or more transducer array layout maps thatinclude non-overlapping positions for transducer array placement. Theplurality of sets of transducer array layout maps may be displayed, forexample, to a user, and/or be selectable, for example, via a userinterface. The user interface may be used to select a transducer arraylayout map, and based on the selection, be presented with sets oftransducer array layout maps of the plurality of sets of transducerarray layout maps that are associated with (e.g., based on a criterion,based on non-overlapping positions, overlapping positions, etc.) theselected transducer array layout map.

An example method may include presenting a plurality of images of ananatomic volume to at least one user, and accepting, from the at leastone user, a selection of which images of the anatomic volume should beused to generate a plurality of transducer array layout maps. The methodmay include generating a model (3D model) of electrical characteristicsof the anatomic volume based on the selected images and determining aplurality of transducer array layouts. Then evaluating, based on thecreated model, which of the determined transducer array layoutssatisfies at least one criterion. The method may include presenting, tothe at least one user, a plurality of transducer array layout maps thatsatisfy the at least one criterion and accepting, from the at least oneuser, a selection of one of the transducer array layouts that waspresented to the at least one user. A report that describes the selectedtransducer array layout may be generated. In some instances, the modelmay also be based on at least one additional image. In some instancesgenerating the model may include performing segmentation based on inputreceived from the at least one user. In some instances, the at least oneuser may include a first user and a second user. The method may alsoinclude accepting an input from the first user identifying a region ofinterest, and outputting data describing the region of interest to thesecond user. In some instances, generating the model may includeperforming segmentation based on input received from the second user. Insome instances, the method may include accepting an input from the firstuser identifying a gross segmentation, and outputting data describingthe gross segmentation to the second user. In some instances, generatingthe model may include performing segmentation based on input receivedfrom the second user. In some instances, the method may includeaccepting at least one note from the first user, and outputting the atleast one note to the second user. In some instances, generating themodel may include performing segmentation based on input received fromthe second user. In some instances, the method may include accepting aninput from the first user identifying an avoidance region, andoutputting data describing the avoidance region to the second user. Insome instances, generating the model may include performing segmentationbased on input received from the second user.

FIG. 10 is a block diagram depicting an example system 1000 for managingtransducer array placement. In some instances, components of the system1000 may be implemented as a single device and/or the like. In someinstances, components of the system 1000 may be implemented as separatedevices/components and/or in collective communication. The system 1000and/or the components of the system 1000 may be implemented as hardware,software, or a combination of both hardware and software. In an aspect,some or all steps of any described method herein may be performed onand/or via components of the system 1000. The system 1000 may be used todetermine positions (locations) for transducer array placement on thebody of a person (e.g., a patient, a subject, etc.). The positions(locations) for transducer array placement may be indicated by one ormore transducer array layout maps. A user (e.g., a physician, a nurse,an assistant, a staff member, a physicist, a dosimetrist, etc.) may usethe system 1000 to generate and/or evaluate a plurality of transducerarray layout maps. The system 1000 enables users that may be higher-costand/or highly skilled personnel (e.g., physicians, etc.) to provideguidance and/or instructions for determining and/or generatingtransducer array layout maps to lower-cost personnel (e.g.,dosimetrists, physicists, etc.). For example, image data (e.g., one ormore images associated with CT, MRI, ultrasound, SPECT, x-ray CT, PET,etc.), may be segmented via a user device and the segmented image datamay be sent to another user device for analysis, used to generate athree-dimensional (3D) model, and/or used to generate a plurality oftransducer array layout maps. Determined and/or generated transducerarray layout maps may be reviewed and/or selected to generate a reportthat may be used for effective TTFields treatment and/or therapy.

The system 1000 may include a patient support module 1001. The patientsupport module 1001 may include a processor 1008. The processor 1008 maybe a hardware device for executing software, particularly that stored inmemory 1010. The processor 1008 may be any custom made or commerciallyavailable processor, a central processing unit (CPU), an auxiliaryprocessor among several processors associated with the patient supportmodule 1001, a semiconductor-based microprocessor (in the form of amicrochip or chip set), or generally any device for executing softwareinstructions. When the patient support module 1001 is in operation, theprocessor 1008 may be configured to execute software stored within thememory 1010, to communicate data to and from the memory 1010, and togenerally control operations of the patient support module 1001 pursuantto the software.

The I/O interfaces 1012 may be used to receive user input from and/orfor providing system output to one or more devices or components, suchas user devices 1020 and 1030. User input may be provided via, forexample, a keyboard, mouse, a data/information communication interface,and/or the like. The I/O interfaces 1012 may include, for example, aserial port, a parallel port, a Small Computer System Interface (SCSI),an IR interface, an RF interface, and/or a universal serial bus (USB)interface.

A network interface 1014 may be used to transmit and receivedata/information from the patient support module 1001. The networkinterface 1014 may include, for example, a 10BaseT Ethernet Adaptor, a100BaseT Ethernet Adaptor, a LAN PHY Ethernet Adaptor, a Token RingAdaptor, a wireless network adapter (e.g., WiFi), or any other suitablenetwork interface device. The network interface 1014 may includeaddress, control, and/or data connections to enable appropriatecommunications.

The memory 1010 (memory system) may include any one or combination ofvolatile memory elements (e.g., random access memory (RAM, such as DRAM,SRAM, SDRAM, etc.)) and nonvolatile memory elements (e.g., ROM, harddrive, tape, CDROM, DVDROM, etc.). Moreover, the memory 1010 mayincorporate electronic, magnetic, optical, and/or other types of storagemedia. In some instances, the memory system 1010 may have a distributedarchitecture, where various components are situated remote from oneanother, but may be accessed by the processor 1008.

The memory 1010 may include one or more software programs, each of whichcomprises an ordered listing of executable instructions for implementinglogical functions. For example the memory 1010 may include the EFGconfiguration application 606, the patient modeling application 608, theimaging data 610, as described in FIG. 6, and a suitable operatingsystem (O/S) 1018. The operating system 1018 may, essentially, controlthe execution of other computer programs, and provides scheduling,input-output control, file and data management, memory management, andcommunication control and related services.

For purposes of illustration, application programs and other executableprogram components such as the operating system 1018 are illustratedherein as discrete blocks, although it is recognized that such programsand components can reside at various times in different storagecomponents of the patient support system 104. An implementation of theEFG configuration application 606, the patient modeling application 608,the imaging data 610, and/or the control software 110 can be stored onor transmitted across some form of computer readable media. Any of thedisclosed methods can be performed by computer readable instructionsembodied on computer readable media. Computer readable media can be anyavailable media that can be accessed by a computer. By way of exampleand not meant to be limiting, computer readable media can comprise“computer storage media” and “communications media.” “Computer storagemedia” can comprise volatile and non-volatile, removable andnon-removable media implemented in any methods or technology for storageof information such as computer readable instructions, data structures,program modules, or other data. Exemplary computer storage media cancomprise RAM, ROM, EEPROM, flash memory or other memory technology,CD-ROM, digital versatile disks (DVD) or other optical storage, magneticcassettes, magnetic tape, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to store thedesired information and which can be accessed by a computer.

The system 1000 may include the user devices 1020 and 1030. The userdevices 1020 and 1030 may be an electronic devices such as computers,smartphones, laptops, tablets, and/or the like capable of communicatingwith a patient support module 1001. Although only the user devices 1020and 1030, the system 1000 may include a plurality of the devices.

The user devices 1020 and 1030 may include an interface module 1022. Theinterface module 1022 may provide an interface for users to interactwith the user devices 1020 and 1030 and/or the patient support module1001. The interface module 1022 my include one or more inputdevices/interfaces such as a keyboard, a pointing device (e.g., acomputer mouse, remote control), a microphone, a joystick, a scanner,haptic sensing and/or tactile input devices, and/or the like.

The interface module 1022 may include one or more interfaces forpresenting and/or receiving information to/from a user (e.g., aphysician, a nurse, an assistant, a staff member, a physicist, adosimetrist, etc.), such as user feedback. The interface module 1022 mayinclude any software, hardware, and/or interfaces used to providecommunication between users and one or more of the user devices 1020 and1030, the patient support module 1001, and/or any other component ofand/or associated with the system 1000. The interface module 1022 mayinclude one or more displays (e.g., monitors, head-up displays, headmounted displays, liquid crystal displays, organic light-emitting diodedisplays, active-matrix organic light-emitting diode displays, stereodisplays, etc.) for displaying/presenting information to the user. Theinterface module 1022 may include one or more audio device (e.g.,stereos, speakers, microphones, etc.) for capturing/obtaining audioinformation and conveying audio information, such as audio informationcaptured/obtained from the user and/or conveyed to the user. Theinterface module 1022 may include a graphical user interface (GUI), aweb browser (e.g., Internet Explorer®, Mozilla Firefox®, Google Chrome®,Safari®, or the like), an application/API. The interface module 1022 mayrequest and/or query various files from a local source and/or a remotesource, such as the patient support module 1001.

The interface module 1022 may transmit/send data/information to a localand/or remote device/component of the system 1000 such as the patientsupport module 1001 and/or another user device (e.g., the user device1020, the user device 1030, etc.). The user devices 1020 and 1030 mayinclude a communication module 1023. The communication module 1023 mayenable the user devices 1020 and 1030 to communicate with components ofthe system 1000, such as the patient support module 1001 and/or anotheruser device, via wired and/or wireless communication techniques. Forexample, the communication module 1023 may utilize any suitable wiredcommunication technique, such as Ethernet, coaxial cable, fiber optics,and/or the like. The communication module 1023 may utilize any suitablelong-range communication technique, such as Wi-Fi (IEEE 802.11),BLUETOOTH®, cellular, satellite, infrared, and/or the like. Thecommunication module 1023 may utilize any suitable short-rangecommunication technique, such as BLUETOOTH®, near-field communication,infrared, and the like.

As described, the system 1000 may be used to determine positions(locations) for transducer array placement on the body of a person(e.g., a patient, a subject, etc.). The positions (locations) fortransducer array placement may be indicated by one or more transducerarray layout maps. A user (e.g., a physician, a nurse, an assistant, astaff member, a physicist, a dosimetrist, etc.) may use the system 1000generate and/or evaluate a plurality of transducer array layout maps.The system 1000 enables users that may be higher-cost and/or highlyskilled personnel (e.g., physicians, etc.) to provide guidance and/orinstructions for determining and/or generating transducer array layoutmaps to lower-cost personnel (e.g., dosimetrists, physicists, etc.). Forexample, the higher-cost and/or highly skilled personnel may use theuser device 1020 to provide guidance and/or instructions for determiningand/or generating transducer array layout maps to the lower-costpersonnel (e.g., dosimetrists, physicists, etc.) who may be a user ofthe user device 1030.

FIGS. 11A-11D show screens of an example interface (e.g., the interfacemodule 1022, etc.) for managing transducer array placement. One or moreimages of a portion of the body (e.g., a head, a torso, an anatomicvolume, etc.) of a subject/patient, for example from the image data 610,may be segmented and used to generate a three-dimensional (3D) model.FIG. 11A shows an example screen 1101 of a user interface 1100. Thescreen 1101 may include subject/patient identifying information 1102.The identifying information 1102 may identify a subject/patientassociated with one or more images used to generate a 3D model.Progression through the user interface 1100 may be enabled and/orindicated by interactive elements 1103 (e.g., tabs, etc.). As indictedby the interactive element 1103, the screen 1101 may be used forsegmentation of image data.

The screen 1101 enables a user (e.g., a user of the user devices 1020and 1030, etc.) to import and inspect one or more images of a portion ofthe body (e.g., a head, a torso, an anatomic volume, etc.) of asubject/patient and determine if the imaged should be used to generate a3D model. The images may be imported, for example, from the patientsupport module 1001, by interacting with an interactive element 1104(e.g., button, etc.). Interacting with an interactive element 1104 maycause a menu that enables the user to search for relevant images and/orupload the relevant images to open. After an image has been imported,from example, from the image data 610, a representation of the imagesmay be shown in a panel 1105. FIG. 11B shows the example screen 1101 ofthe user interface 1100 when images have been imported and arerepresented in the panel 1105 by the images 1106. The user can view andinspect the imported images 1106, for example, by using an interactiveelement (e.g., mouse, touch pad, etc.) to drag one or more of the images1106 to one or more windows 1107 of the screen 1101. The user mayidentify images (e.g., one or more images, sets of images, etc.) bestsuited for TTFields treatment planning. As shown in FIG. 11B, one ormore of the images 1106 are represented in the windows 1107.

After viewing/inspecting the images 1106 the user may select an image orsets of images to be segmented and used to generate a 3D model. In someinstances, a user of the user device 1020 may select an image or sets ofimages, and the user device 1020 may send the selected image or sets ofimages (e.g., information associated with the selected image or sets ofimages, etc.) to the user device 1030 for segmentation and 3D modelgeneration. In some instances, a user of the user device 1030 may selectan image or sets of images, and the user device 1030 may send theselected image or sets of images (e.g., information associated with theselected image or sets of images, etc.) to the user device 1020 forsegmentation and 3D model generation. When selecting an image or sets ofimages, an image may be marked with an element 1108, such as an “anchor”icon that indicates that the image is a primary (“anchor”) image thatwill be used to generate the computational 3D model and/or transducerarray layout map. Other images may be marked as “assisting images” toindicate that the user has optionally selected the images to assist ingenerating the 3D model and/or transducer array layout map. Theassisting images may be registered to the primary image to improve theaccuracy of the 3D model. In some instances, the quality of a 3D modeland/or transducer array layout map may be proportional to the number ofimages used to generate the 3D model and/or transducer array layout map.

The user may select images represented in the one or more windows 1107.After images have been selected, the images may be segmented toidentify/determine/select features of and/or regions-of-interest withinthe images, such as represented tumor and/or abnormal tissue structures.The user interface 1100 may be configured with segmentation tools (e.g.,semi-automatic segmentation tool, manual segmentation tools, etc.)and/or algorithms that enable the user to mark features, structures,and/or regions-of-interest (RO1) within the images. For example, thesegmentation tools may enable the user to mark areas of images as anenhancing tumor, a necrotic core, a resection cavity, craniotomy, and/orthe like. The area 1109 of the screen 1101 shows examples of structuresin images that may be defined by a user, such as tissue types, ROIs, andavoidance structures/areas. An avoidance structure/area may be anyregion on the surface of the body of a subject/patient where atransducer arrays should not be placed, such as an area of scar tissue,medical apparatus implantation, and/or the like.

As described, a user may assign tissue types to images used to generatea 3D model and/or transducer array layout map. When a user assigns atissue type to a specific voxel of an image, a corresponding voxel in a3D model is assigned the same tissue type dielectric and/or electricproperties associated with the tissue type. Each ROI determined and/orselected by a user may be assigned a unique label. The user interface1100 enables any determined and/or selected ROI to be optionally markedon images used to generate a 3D model and/or transducer array layoutmap. In some instances, any determined and/or selected ROI may be usedby an electrical field distribution simulation and/or optimizationalgorithm to generate transducer array layout maps. In some instances,ROIs may be imported to the system 1000 from an outside source (e.g., athird-party software used for planning radiation therapy, etc.). After auser completes segmentation edits to images, an interactive element 1110may be interacted with and/or selected to generate a 3D model.

FIG. 11C shows an example screen 1111 of the user interface 1100. Thescreen 1111 may be a progression screen of the screen 1101. As shown,the interactive element 1103 is set to “model” to indicate theprogression through of the user interface 1100. The screen 1111 maydisplay any abnormal tissues indicated on the screen 1101 and any normalbody tissues (e.g., gray matter, white matter, skull, scalp, and CSF)within images. The user interface 1100 may be configured toautomatically add and/or include any normal body tissues when generatinga 3D model.

A generated 3D model may model any electrical characteristics at everypoint in space within a portion of the body (e.g., a head, a torso, ananatomic volume, etc.) of a subject/patient. For example, the system1000 may map electrical characteristics to 3D models. Mapping electricalcharacteristics to 3D models may be based on Diffusion Tensor ImagingMRI data (DTI), Water Electric Property Tomography (wEPT), machinelearning, and/or any other method/technique for associating electricalcharacteristics to tissue types based on image data. Once a 3D model isgenerated, the user interface 1100 enables a user to positioningsimulated transducer arrays at various positions (locations) on the 3Dmodel, simulate the application of AC voltages to the simulatedtransducer arrays, execute simulations that determine a resultingelectric field distribution and/or power density at every point withinthe portion of the body (e.g., a head, a torso, an anatomic volume,etc.) of a subject/patient represented by the 3D model. The 3D model maybe displayed to a user. If the user is not satisfied with the displayedmodel, an interactive element 1112 “view segmentation,” for example, maybe used to return to a previous screen, such as a segmentation inputscreen of the user interface 1100. If the user is satisfied with thedisplayed model, an interactive element 1113 “create plan,” for example,may be used to proceed to a next screen of the user interface 1100.

FIG. 11D shows an example screen 1114 of the user interface 1100. A usermay interact with the interactive element 1103 “plan,” for example toprogress to the screen 1114. The screen 1114, for example, may be usedanalyze, evaluate, and/or select a TTfields treatment plan. For example,after a 3D is generated and a plurality of simulated electrical fielddistributions are determined based on the 3D model, a plurality oftransducer array layout maps may be generated. In some instances, thesystem 1000 may determine the plurality of transducer array layouts, forexample, from a library, record, corpus, and/or the like of standardtransducer array layouts. In some instances, the system 1000 maydetermine the plurality of transducer array layouts, for example,enabling a user to use the user interface 1100 to varying the positionsof one or more arrays to converge on a transducer array layout map thatprovides desired and/or the best (e.g., most suitable for satisfying acriterion, etc.) results. The system 1000, based on varying thepositions of one or more arrays as described, may determine one or moretransducer array layout maps (e.g., sets of transducer array layoutmays, etc.) of a plurality of transducer array layout maps thatoptimizes electric field distribution within a target ROI while alsosatisfying constraints associated with transducer array placementimposed by avoidance structures. For example, one or more sets oftransducer array layout maps may be determined (e.g., automatically,manually selected, etc.) from the plurality of transducer array layoutmaps that each represents at least two transducer array layout maps withnon-overlapping positions and/or satisfy a criterion. As described, acriterion may include a magnitude of a simulated electric fielddistribution within a ROI associated with a 3D model, a power densityassociated with a simulated electric field distribution within the ROI,and/or the like. In some instances, a criterion may be based on anestimate of skin toxicity associated with a portion of the body of asubject/patient where transducer arrays are to be place and/or anavoidance area.

The best transducer array layout maps for a desired TTFields treatmentplan may be determined to generate composite data (e.g., a report, aplan, a summary, etc.). The composite data, for example, may includeinformation associated with the transducer array layout maps andassociated simulated electrical field distributions. The composite datamay be displayed, for example, via the user interface 1100. Returning toFIG. 11D, the screen 1114 may display electric field distributions(e.g., represented as one or more colormaps, etc.) associated with eachtransducer array layout map of the plurality of transducer array layoutmaps. For example, interactive elements 1115, may be used to viewelectric field distribution for each of the transducer array layout map(TALs) by interacting with a corresponding TAL element (e.g., TAL 1through TAL 5). As shown, the TAL 1 of the interactive elements 1115 isselected and a colormap of the electric field distribution and theassociated transducer array layout map are displayed in regions 1116 and1117, respectively. A table summarizing the electric field dosedelivered to target ROIs for each transducer array layout map of theplurality of transducer array layout maps may be displayed to enable auser to select a TTFields treatment plan. In some instances, an overallscore for each transducer array layout map and/or set of transducerarray layout maps of the plurality of transducer array layout maps maybe determined and displayed. A score may represent a degree ofsatisfaction of a criterion or criteria by an associated transducerarray layout map. Scores may be color-coded (e.g., green for the highestscores, yellow for intermediate scores, and red for low scores). Theplurality of transducer array layout maps and/or sets of transducerarray layout maps of the plurality of transducer array layout maps mayranked according to any method, algorithm, and/or criteria, and theranking may be displayed to a user.

The user interface 1100 enables the plurality of transducer array layoutmaps and/or sets of transducer array layout maps to be evaluated, forexample, by a user. An evaluation of a transducer array layout map bebased on and/or determine a quality of a 3D model used to generatetransducer array layout map (e.g., the TTFields treatment plan, etc.). Auser may evaluate and select one or more transducer array layout mapsand/or sets of transducer array layout maps of the plurality oftransducer array layout maps.

FIG. 12, shows a flowchart of a method 1200 for managing transducerarray placement. One or more of the apparatus 100, the patient supportsystem 602, the patient modeling application 608, the system 1000,and/or any other device/component described herein can be configured toperform a method 1200 comprising, at 1210, generating athree-dimensional (3D) model of a portion of the subject's body.Generating the 3D model may be based on image data from any modality ofimaging, such as one or more images associated with CT, MRI, ultrasound,SPECT, x-ray CT, PET, a combination thereof, and/or the like. In someinstances, one or more user devices may display a plurality of images ofthe portion of the subject's body. A selection of one or more images ofthe plurality of images may be received based on a region-of-interest(ROI), and a 3D model may be generated based on the one or more images.For example, an ROI may be based on features and/or structures withinthe one or more images, such as an enhancing tumor, a necrotic core, aresection cavity, craniotomy, and/or the like. In some instancesreceiving information associated with the ROI may be received from afirst user device of the one or more user devices, and a selection ofthe one or more images may be received from a second user device of theone or more user device.

At 1220, determining, based on the 3D model and a plurality of simulatedelectrical field distributions, a plurality of transducer array layoutmaps. Determining the plurality of transducer array layout maps mayinclude determining, based on the 3D model, a plurality of pairs ofpositions for transducer array placement. In some instances, theplurality of pairs of positions for transducer array placement may bedetermined from a library, record, corpus, and/or the like of standardtransducer array layouts. In some instances, the plurality of pairs ofpositions for transducer array placement may be determined and/orselected to avoid one or more regions within the 3D model (e.g.,avoidance regions, etc.), and/or the like. For each pair of positions ofthe plurality of pairs positions, a simulated electrical fielddistribution of the plurality of simulated electrical fielddistributions may be determined. Determining the simulated electricalfield distribution for each pair of positions of the plurality of pairspositions may include simulating, at a first position of the pair ofpositions, a first electrical field generated by a first transducerarray, and simulating, at a second position of the pair of positions, asecond electrical field generated by a second transducer array. Thesecond position may be opposite the first position. In some instances, athird electrical field generated by the first transducer array may besimulated at a third position, and a fourth electrical field generatedby the second transducer array may be simulated at a fourth positionopposite the third position, and, based on the third electrical fieldand the fourth electrical field, the simulated electrical fielddistribution may be determined. The simulated electrical fielddistribution may be determined based on the first electrical field andthe second electrical field and/or the third electrical field and thefourth electrical field. The plurality of transducer array layout mapsmay be determined based on the plurality of simulated electrical fielddistributions.

At 1230, determining, from the plurality of transducer array layoutmaps, one or more sets of transducer array layout maps, wherein each setof transducer array layout maps represents at least two transducer arraylayout maps with non-overlapping positions of a plurality of pairs ofpositions for transducer array placement, wherein the at least twotransducer array layout maps satisfy a criterion. The criterion mayinclude a magnitude of a simulated electric field distribution of theplurality of simulated electrical field distributions within aregion-of-interest (ROI) associated with the 3D model, a power densityassociated with a simulated electric field distribution of the pluralityof simulated electrical field distributions within the ROI, and anestimate of skin toxicity associated with the portion of the subject'sbody.

At 1240, causing display of the one or more sets of transducer arraylayout maps. The one or more sets of transducer array layout maps may bedisplayed by an interface of the one or more user devices. A selectionof a set of transducer array layout maps of the one or more sets oftransducer array layout maps may be received, for example via aninterface of the one or more user devices. Composite data (e.g., areport, a plan, a summary, etc.) may be generated based on the selectedset of transducer array layout maps. The composite data may includeinformation associated with the selected set of transducer array layoutmaps and simulated electrical field distributions of the plurality ofsimulated electrical field distributions associated with the selectedset of transducer array layout maps. The composite data may be sent tothe one or more user devices.

FIG. 13, shows a flowchart of a method 1300 for managing transducerarray placement. One or more of the apparatus 100, the patient supportsystem 602, the patient modeling application 608, the system 1000,and/or any other device/component described herein can be configured toperform a method 1300 comprising, at 1310, generating athree-dimensional (3D) model of a portion of the subject's body.Generating the 3D model may be based on image data from any modality ofimaging, such as one or more images associated with CT, MRI, ultrasound,SPECT, x-ray CT, PET, a combination thereof, and/or the like. In someinstances, one or more user devices may display a plurality of images ofthe portion of the subject's body. A selection of one or more images ofthe plurality of images may be received based on a region-of-interest(ROI), and a 3D model may be generated based on the one or more images.For example, an ROI may be based on features and/or structures withinthe one or more images, such as an enhancing tumor, a necrotic core, aresection cavity, craniotomy, and/or the like. In some instancesreceiving information associated with the ROI may be received from afirst user device of the one or more user devices, and a selection ofthe one or more images may be received from a second user device of theone or more user device.

At 1320, determining, based on the 3D model and a plurality of simulatedelectrical field distributions, a plurality of transducer array layoutmaps. Determining the plurality of transducer array layout maps mayinclude determining, based on the 3D model, a plurality of pairs ofpositions for transducer array placement. In some instances, theplurality of pairs of positions for transducer array placement may bedetermined from a library, record, corpus, and/or the like of standardtransducer array layouts. In some instances, the plurality of pairs ofpositions for transducer array placement may be determined and/orselected to avoid one or more regions within the 3D model (e.g.,avoidance regions, etc.), and/or the like. For each pair of positions ofthe plurality of pairs positions, a simulated electrical fielddistribution of the plurality of simulated electrical fielddistributions may be determined. Determining the simulated electricalfield distribution for each pair of positions of the plurality of pairspositions may include simulating, at a first position of the pair ofpositions, a first electrical field generated by a first transducerarray, and simulating, at a second position of the pair of positions, asecond electrical field generated by a second transducer array. Thesecond position may be opposite the first position. In some instances, athird electrical field generated by the first transducer array may besimulated at a third position, and a fourth electrical field generatedby the second transducer array may be simulated at a fourth positionopposite the third position, and, based on the third electrical fieldand the fourth electrical field, the simulated electrical fielddistribution may be determined. The simulated electrical fielddistribution may be determined based on the first electrical field andthe second electrical field and/or the third electrical field and thefourth electrical field. The plurality of transducer array layout mapsmay be determined based on the plurality of simulated electrical fielddistributions.

At 1330, receiving a selection of a first transducer array layout map ofthe plurality of transducer array layout maps, wherein the firsttransducer array layout map satisfies a criterion. The selection firsttransducer array layout may be received from one or more user devices.The criterion may include a magnitude of a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within a region-of-interest (ROI) associated with the 3Dmodel, a power density associated with a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within the ROI, and an estimate of skin toxicityassociated with the portion of the subject's body.

At 1340, determining, from the plurality of transducer array layoutmaps, one or more associated transducer array layout maps. Eachassociated transducer array layout map may include positions fortransducer array placement that do not overlap positions for transducerarray placement of the first transducer array layout map. In someinstances, each associated transducer array layout map may satisfy thecriterion.

At 1350, receiving a selection of a second transducer array layout mapfrom the one or more associated transducer array layout maps.

At 1360, causing display of the first transducer array layout map andthe second transducer array layout map. In some instances, compositedata (e.g., a report, a plan, a summary, etc.) may be generated based onthe first transducer array layout map and the second transducer arraylayout map. The composite data may include, for example, informationassociated with the first transducer array layout map and the secondtransducer array layout map and simulated electrical field distributionsof the plurality of simulated electrical field distributions associatedwith the first transducer array layout map and the second transducerarray layout map.

FIG. 14, shows a flowchart of a method 1400 for managing transducerarray placement. One or more of the apparatus 100, the patient supportsystem 602, the patient modeling application 608, the system 1000,and/or any other device/component described herein can be configured toperform a method 1300 comprising, at 1410, generating athree-dimensional (3D) model of a portion of the subject's body.Generating the 3D model may be based on image data from any modality ofimaging, such as one or more images associated with CT, MRI, ultrasound,SPECT, x-ray CT, PET, a combination thereof, and/or the like. In someinstances, one or more user devices may display a plurality of images ofthe portion of the subject's body. A selection of one or more images ofthe plurality of images may be received based on a region-of-interest(ROI), and a 3D model may be generated based on the one or more images.For example, an ROI may be based on features and/or structures withinthe one or more images, such as an enhancing tumor, a necrotic core, aresection cavity, craniotomy, and/or the like. In some instancesreceiving information associated with the ROI may be received from afirst user device of the one or more user devices, and a selection ofthe one or more images may be received from a second user device of theone or more user device.

At 1420, determining, based on the 3D model and a plurality of simulatedelectrical field distributions, a plurality of transducer array layoutmaps. Determining the plurality of transducer array layout maps mayinclude determining, based on the 3D model, a plurality of pairs ofpositions for transducer array placement. In some instances, theplurality of pairs of positions for transducer array placement may bedetermined from a library, record, corpus, and/or the like of standardtransducer array layouts. In some instances, the plurality of pairs ofpositions for transducer array placement may be determined and/orselected to avoid one or more regions within the 3D model (e.g.,avoidance regions, etc.), and/or the like. For each pair of positions ofthe plurality of pairs positions, a simulated electrical fielddistribution of the plurality of simulated electrical fielddistributions may be determined. Determining the simulated electricalfield distribution for each pair of positions of the plurality of pairspositions may include simulating, at a first position of the pair ofpositions, a first electrical field generated by a first transducerarray, and simulating, at a second position of the pair of positions, asecond electrical field generated by a second transducer array. Thesecond position may be opposite the first position. In some instances, athird electrical field generated by the first transducer array may besimulated at a third position, and a fourth electrical field generatedby the second transducer array may be simulated at a fourth positionopposite the third position, and, based on the third electrical fieldand the fourth electrical field, the simulated electrical fielddistribution may be determined. The simulated electrical fielddistribution may be determined based on the first electrical field andthe second electrical field and/or the third electrical field and thefourth electrical field. The plurality of transducer array layout mapsmay be determined based on the plurality of simulated electrical fielddistributions.

At 1430, receiving a selection of a first transducer array layout mapand a second transducer array layout map of the plurality of transducerarray layout maps. The selection of the first transducer array layoutmap and the second transducer array layout map may be received via aninterface of one or more user devices.

At 1430, determining, based on the first transducer array layout map andthe second transducer array layout map, an overlap condition. Eachtransducer array layout map of the plurality of transducer array layoutmaps may include one or more pairs of positions of a plurality of pairsof positions for transducer array placement. The overlap condition mayindicate that the first transducer array layout map comprises one ormore pairs of positions of the plurality of pairs of positions thatoverlap one or more pairs of positions of the plurality of pairs ofpositions associated with the second transducer array layout map. Forexample, the first transducer array layout map may include positions fortransducer arrays that are at the same position indicated on a 3D model(e.g., overlap, etc.) or the positions are at position indicated on a 3Dmodel that satisfy a distance threshold and/or with in a tolerancepositioning range relative to each other (e.g., substantially overlap,etc.).

At 1430, causing display of the overlap condition. One or more of theuser device may be caused to display, for example via and interface,display, and/or the like, the overlap condition. In some cases, theoverlap condition may be indicated by an audible sound and/or anotification.

In view of the described apparatuses, systems, and methods andvariations thereof, herein below are described certain more particularlydescribed embodiments of the invention. These particularly recitedembodiments should not however be interpreted to have any limitingeffect on any different claims containing different or more generalteachings described herein, or that the “particular” embodiments aresomehow limited in some way other than the inherent meanings of thelanguage literally used therein.

Embodiment 1: A method comprising: generating a three-dimensional (3D)model of a portion of the subject's body, determining, based on the 3Dmodel and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, determining, from theplurality of transducer array layout maps, one or more sets oftransducer array layout maps, wherein each set of transducer arraylayout maps represents at least two transducer array layout maps withnon-overlapping positions of a plurality of pairs of positions fortransducer array placement, wherein the at least two transducer arraylayout maps satisfy a criterion, and causing display of the one or moresets of transducer array layout maps.

Embodiment 2: The embodiment as in any one of the preceding embodimentswherein the criterion comprises a magnitude of a simulated electricfield distribution of the plurality of simulated electrical fielddistributions within a region-of-interest (ROI) associated with the 3Dmodel, a power density associated with a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within the ROI, and an estimate of skin toxicityassociated with the portion of the subject's body.

Embodiment 3: The embodiment as in any one of the preceding embodiments,further comprising receiving a selection of a set of transducer arraylayout maps of the one or more sets of transducer array layout maps.

Embodiment 4: The embodiment as in the embodiment 3, further comprisinggenerating, based on the selected set of transducer array layout maps,composite data.

Embodiment 5: The embodiment as in the embodiment 4, wherein thecomposite data comprises information associated with the selected set oftransducer array layout maps and simulated electrical fielddistributions of the plurality of simulated electrical fielddistributions associated with the selected set of transducer arraylayout maps.

Embodiment 6: The embodiment as in the embodiment 4, further comprisingsending, to a user device, the composite data.

Embodiment 7: The embodiment as in any one of the preceding embodiments,wherein generating the 3D model comprises: causing one or more userdevices to display a plurality of images of the portion of the subject'sbody, receiving, based on a region-of-interest (ROI), a selection of oneor more images of the plurality of images, and generating, based on theone or more images, the 3D model.

Embodiment 8: The embodiment as in the embodiment 7, further comprisingreceiving, from a first user device of the one or more user devices,information associated with the ROI, and wherein receiving the selectionof the one or more images comprises receiving the selection of the oneor more images from a second user device of the one or more userdevices.

Embodiment 9: The embodiment as in any one of the preceding embodiments,wherein determining the plurality of transducer array layout mapscomprises: determining, based on the 3D model, the plurality of pairs ofpositions for transducer array placement, determining, for each pair ofpositions of the plurality of pairs positions, a simulated electricalfield distribution of the plurality of simulated electrical fielddistributions, and determining, based on the plurality of simulatedelectrical field distributions, the plurality of transducer array layoutmaps.

Embodiment 10: The embodiment as in embodiment 9, wherein determiningthe simulated electrical field distribution for each pair of positionsof the plurality of pairs positions comprises: simulating, at a firstposition of the pair of positions, a first electrical field generated bya first transducer array, simulating, at a second position of the pairof positions, a second electrical field generated by a second transducerarray, wherein the second position is opposite the first position, anddetermining, based on the first electrical field and the secondelectrical field, the simulated electrical field distribution.

Embodiment 11: A method comprising: generating a three-dimensional (3D)model of a portion of the subject's body, determining, based on the 3Dmodel and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, receiving a selection of afirst transducer array layout map of the plurality of transducer arraylayout maps, wherein the first transducer array layout map satisfies acriterion, determining, from the plurality of transducer array layoutmaps, one or more associated transducer array layout maps, wherein eachassociated transducer array layout map comprises positions fortransducer array placement that do not overlap positions for transducerarray placement of the first transducer array layout map, wherein eachassociated transducer array layout map satisfies the criterion,receiving a selection of a second transducer array layout map from theone or more associated transducer array layout maps, and causing displayof the first transducer array layout map and the second transducer arraylayout map.

Embodiment 12: The embodiment as in the embodiment 11, wherein thecriterion comprises a magnitude of a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within a region-of-interest (ROI) associated with the 3Dmodel, a power density associated with a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within the ROI, and an estimate of skin toxicityassociated with the portion of the subject's body.

Embodiment 13: The embodiment as in any one of the embodiments 11-12,further comprising generating, based on the first transducer arraylayout map and the second transducer array layout map, composite data.

Embodiment 14: The embodiment as in the embodiment 13, wherein thecomposite data comprises information associated with the firsttransducer array layout map and the second transducer array layout mapand simulated electrical field distributions of the plurality ofsimulated electrical field distributions associated with the firsttransducer array layout map and the second transducer array layout map.

Embodiment 15: The embodiment as in any one of the embodiments 11-14,wherein generating the 3D model comprises: causing one or more userdevices to display a plurality of images of the portion of the subject'sbody, receiving, based on a region-of-interest (ROI), a selection of oneor more images of the plurality of images, and generating, based on theone or more images, the 3D model.

Embodiment 16: The embodiment as in the embodiment 15, furthercomprising receiving, from a first user device of the one or more userdevices, information associated with the ROI, and wherein receiving theselection of the one or more images comprises receiving the selection ofthe one or more images from a second user device of the one or more userdevices.

Embodiment 17: The embodiment as in any one of the embodiments 11-16,wherein determining the plurality of transducer array layout mapscomprises: determining, based on the 3D model, a plurality of pairs ofpositions for transducer array placement, determining, for each pair ofpositions of the plurality of pairs positions, a simulated electricalfield distribution of the plurality of simulated electrical fielddistributions, and determining, based on the plurality of simulatedelectrical field distributions, the plurality of transducer array layoutmaps.

Embodiment 18: The embodiment as in the embodiment 17, whereindetermining the simulated electrical field distribution for each pair ofpositions of the plurality of pairs positions comprises: simulating, ata first position of the pair of positions, a first electrical fieldgenerated by a first transducer array, simulating, at a second positionof the pair of positions, a second electrical field generated by asecond transducer array, wherein the second position is opposite thefirst position, and determining, based on the first electrical field andthe second electrical field, the simulated electrical fielddistribution.

Embodiment 19: A method comprising: generating a three-dimensional (3D)model of a portion of the subject's body, determining, based on the 3Dmodel and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps, receiving a selection of afirst transducer array layout map and a second transducer array layoutmap of the plurality of transducer array layout maps, determining, basedon the first transducer array layout map and the second transducer arraylayout map, an overlap condition, and causing display of the overlapcondition.

Embodiment 20: The embodiment as in the embodiment 19, wherein eachtransducer array layout map of the plurality of transducer array layoutmaps comprises one or more pairs of positions of a plurality of pairs ofpositions for transducer array placement, wherein the overlap conditionindicates that the first transducer array layout map comprises one ormore pairs of positions of the plurality of pairs of positions thatoverlap one or more pairs of positions of the plurality of pairs ofpositions associated with the second transducer array layout map.

Embodiment 21: A method comprising: presenting a plurality of images ofan anatomic volume to at least one user; accepting, from the at leastone user, a selection of which images of the anatomic volume should beused to generate the transducer array layouts; creating a model ofelectrical characteristics of the anatomic volume based on the selectedimages; determining a plurality of transducer array layouts; evaluating,based on the created model, which of the determined transducer arraylayouts satisfies at least one criterion; presenting, to the at leastone user, a plurality of transducer array layouts that satisfy the atleast one criterion; accepting, from the at least one user, a selectionof one of the transducer array layouts that was presented to the atleast one user; and generating a report that describes the selectedtransducer array layout.

Embodiment 22: The embodiment as in the embodiment 21, wherein the modelof electrical characteristics of the anatomic volume is also based on atleast one additional image.

Embodiment 23: The embodiment as in any one of the embodiments 21-22,wherein creating the model comprises performing segmentation based oninput received from the at least one user.

Embodiment 24: The embodiment as in any one of the embodiments 21-23,wherein the at least one user comprises a first user and a second user,wherein the method further comprises (a) accepting an input from thefirst user identifying a region of interest, and (b) outputting datadescribing the region of interest to the second user.

Embodiment 25: The embodiment as in the embodiment 24, wherein creatingthe model comprises performing segmentation based on input received fromthe second user.

Embodiment 26: The embodiment as in any one of the embodiments 21-25,wherein the at least one user comprises a first user and a second user,wherein the method further comprises: accepting an input from the firstuser identifying a gross segmentation; and outputting data describingthe gross segmentation to the second user.

Embodiment 27: The embodiment as in the embodiment 26, wherein creatingthe model comprises performing segmentation based on input received fromthe second user.

Embodiment 28: The embodiment as in any one of the embodiments 21-27,wherein the at least one user comprises a first user and a second user,wherein the method further comprises (a) accepting at least one notefrom the first user, and (b) outputting the at least one note to thesecond user.

Embodiment 29: The embodiment as in the embodiment 28, wherein creatingthe model comprises performing segmentation based on input received fromthe second user.

Embodiment 30: The embodiment as in any one of the embodiments 21-29,wherein the at least one user comprises a first user and a second user,wherein the method further comprises (a) accepting an input from thefirst user identifying an avoidance region, and (b) outputting datadescribing the avoidance region to the second user.

Embodiment 31: The embodiment as in the embodiment 30, wherein creatingthe model comprises performing segmentation based on input received fromthe second user.

Unless otherwise expressly stated, it is in no way intended that anymethod set forth herein be construed as requiring that its steps beperformed in a specific order. Accordingly, where a method claim doesnot actually recite an order to be followed by its steps or it is nototherwise specifically stated in the claims or descriptions that thesteps are to be limited to a specific order, it is in no way intendedthat an order be inferred, in any respect. This holds for any possiblenon-express basis for interpretation, including: matters of logic withrespect to arrangement of steps or operational flow; plain meaningderived from grammatical organization or punctuation; the number or typeof embodiments described in the specification.

While the methods and systems have been described in connection withpreferred embodiments and specific examples, it is not intended that thescope be limited to the particular embodiments set forth, as theembodiments herein are intended in all respects to be illustrativerather than restrictive.

Unless otherwise expressly stated, it is in no way intended that anymethod set forth herein be construed as requiring that its steps beperformed in a specific order. Accordingly, where a method claim doesnot actually recite an order to be followed by its steps or it is nototherwise specifically stated in the claims or descriptions that thesteps are to be limited to a specific order, it is in no way intendedthat an order be inferred, in any respect. This holds for any possiblenon-express basis for interpretation, including: matters of logic withrespect to arrangement of steps or operational flow; plain meaningderived from grammatical organization or punctuation; the number or typeof embodiments described in the specification.

It will be apparent to those skilled in the art that variousmodifications and variations can be made without departing from thescope or spirit. Other embodiments will be apparent to those skilled inthe art from consideration of the specification and practice disclosedherein. It is intended that the specification and examples be consideredas exemplary only, with a true scope and spirit being indicated by thefollowing claims.

What is claimed is:
 1. A method comprising: generating athree-dimensional (3D) model of a portion of the subject's body;determining, based on the 3D model and a plurality of simulatedelectrical field distributions, a plurality of transducer array layoutmaps; determining, from the plurality of transducer array layout maps,one or more sets of transducer array layout maps, wherein each set oftransducer array layout maps represents at least two transducer arraylayout maps with non-overlapping positions of a plurality of pairs ofpositions for transducer array placement, wherein the at least twotransducer array layout maps satisfy a criterion; and causing display ofthe one or more sets of transducer array layout maps.
 2. The method ofclaim 1, wherein the criterion comprises a magnitude of a simulatedelectric field distribution of the plurality of simulated electricalfield distributions within a region-of-interest (ROI) associated withthe 3D model, a power density associated with a simulated electric fielddistribution of the plurality of simulated electrical fielddistributions within the ROI, and an estimate of skin toxicityassociated with the portion of the subject's body.
 3. The method ofclaim 1, further comprising receiving a selection of a set of transducerarray layout maps of the one or more sets of transducer array layoutmaps.
 4. The method of claim 3, further comprising generating, based onthe selected set of transducer array layout maps, composite data.
 5. Themethod of claim 4, wherein the composite data comprises informationassociated with the selected set of transducer array layout maps andsimulated electrical field distributions of the plurality of simulatedelectrical field distributions associated with the selected set oftransducer array layout maps.
 6. The method of claim 4, furthercomprising sending, to a user device, the composite data.
 7. The methodof claim 1, wherein generating the 3D model comprises: causing one ormore user devices to display a plurality of images of the portion of thesubject's body; receiving, based on a region-of-interest (ROI), aselection of one or more images of the plurality of images; andgenerating, based on the one or more images, the 3D model.
 8. The methodof claim 7, further comprising receiving, from a first user device ofthe one or more user devices, information associated with the ROI, andwherein receiving the selection of the one or more images comprisesreceiving the selection of the one or more images from a second userdevice of the one or more user devices.
 9. The method of claim 1,wherein determining the plurality of transducer array layout mapscomprises: determining, based on the 3D model, the plurality of pairs ofpositions for transducer array placement; determining, for each pair ofpositions of the plurality of pairs positions, a simulated electricalfield distribution of the plurality of simulated electrical fielddistributions; and determining, based on the plurality of simulatedelectrical field distributions, the plurality of transducer array layoutmaps.
 10. The method of claim 9, wherein determining the simulatedelectrical field distribution for each pair of positions of theplurality of pairs positions comprises: simulating, at a first positionof the pair of positions, a first electrical field generated by a firsttransducer array; simulating, at a second position of the pair ofpositions, a second electrical field generated by a second transducerarray, wherein the second position is opposite the first position; anddetermining, based on the first electrical field and the secondelectrical field, the simulated electrical field distribution.
 11. Amethod comprising: generating a three-dimensional (3D) model of aportion of the subject's body; determining, based on the 3D model and aplurality of simulated electrical field distributions, a plurality oftransducer array layout maps; receiving a selection of a firsttransducer array layout map of the plurality of transducer array layoutmaps, wherein the first transducer array layout map satisfies acriterion; determining, from the plurality of transducer array layoutmaps, one or more associated transducer array layout maps, wherein eachassociated transducer array layout map comprises positions fortransducer array placement that do not overlap positions for transducerarray placement of the first transducer array layout map, wherein eachassociated transducer array layout map satisfies the criterion;receiving a selection of a second transducer array layout map from theone or more associated transducer array layout maps; and causing displayof the first transducer array layout map and the second transducer arraylayout map.
 12. The method of claim 11, wherein the criterion comprisesa magnitude of a simulated electric field distribution of the pluralityof simulated electrical field distributions within a region-of-interest(ROI) associated with the 3D model, a power density associated with asimulated electric field distribution of the plurality of simulatedelectrical field distributions within the ROI, and an estimate of skintoxicity associated with the portion of the subject's body.
 13. Themethod of claim 11, further comprising generating, based on the firsttransducer array layout map and the second transducer array layout map,composite data.
 14. The method of claim 13, wherein the composite datacomprises information associated with the first transducer array layoutmap and the second transducer array layout map and simulated electricalfield distributions of the plurality of simulated electrical fielddistributions associated with the first transducer array layout map andthe second transducer array layout map.
 15. The method of claim 11,wherein generating the 3D model comprises: causing one or more userdevices to display a plurality of images of the portion of the subject'sbody; receiving, based on a region-of-interest (ROI), a selection of oneor more images of the plurality of images; and generating, based on theone or more images, the 3D model.
 16. The method of claim 15, furthercomprising receiving, from a first user device of the one or more userdevices, information associated with the ROI, and wherein receiving theselection of the one or more images comprises receiving the selection ofthe one or more images from a second user device of the one or more userdevices.
 17. The method of claim 11, wherein determining the pluralityof transducer array layout maps comprises: determining, based on the 3Dmodel, a plurality of pairs of positions for transducer array placement;determining, for each pair of positions of the plurality of pairspositions, a simulated electrical field distribution of the plurality ofsimulated electrical field distributions; and determining, based on theplurality of simulated electrical field distributions, the plurality oftransducer array layout maps.
 18. The method of claim 17, whereindetermining the simulated electrical field distribution for each pair ofpositions of the plurality of pairs positions comprises: simulating, ata first position of the pair of positions, a first electrical fieldgenerated by a first transducer array; simulating, at a second positionof the pair of positions, a second electrical field generated by asecond transducer array, wherein the second position is opposite thefirst position; and determining, based on the first electrical field andthe second electrical field, the simulated electrical fielddistribution.
 19. A method comprising: generating a three-dimensional(3D) model of a portion of the subject's body; determining, based on the3D model and a plurality of simulated electrical field distributions, aplurality of transducer array layout maps; receiving a selection of afirst transducer array layout map and a second transducer array layoutmap of the plurality of transducer array layout maps; determining, basedon the first transducer array layout map and the second transducer arraylayout map, an overlap condition; and causing display of the overlapcondition.
 20. The method of claim 19, wherein each transducer arraylayout map of the plurality of transducer array layout maps comprisesone or more pairs of positions of a plurality of pairs of positions fortransducer array placement, wherein the overlap condition indicates thatthe first transducer array layout map comprises one or more pairs ofpositions of the plurality of pairs of positions that overlap one ormore pairs of positions of the plurality of pairs of positionsassociated with the second transducer array layout map.